On 2nd September an amendment was published to EU No 10/2011 on plastic materials and articles intended to come into contact with food.

The amendment is EU 2020/1245 of 2 September 2020.

The consolidated text of EU No 10/2011 on plastic materials and articles intended to come into contact with food, includes the amends with the exception of the specific dates.

What are the amendments?

All the changes relating to EU 2020/1245 are shown in the consolidated text, wherever you see ‘M15’. We have highlighted these on our copy.

The following table shows the changes, by comparing the previous consolidated text with the updated version. At the end of the article we’ve summarised for you.

Pg Previous Pg Amended
6

Article 6
Derogations for substances not included in the Union list

3. The following substances not included in the Union list are authorised subject to the rules set out in Articles 8, 9, 10, 11 and 12:

(a) all salts of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium, and zinc of authorised acids, phenols or alcohols;

6

Article 6
Derogations for substances not included in the Union list

3. The following substances not included in the Union list are authorised subject to the rules set out in Articles 8, 9, 10, 11 and 12:

(a) all salts of substances for which ‘yes’ is indicated in column 2 in Table 1 of Annex II of authorised acids, phenols or alcohols, and subject to the restrictions set out in column 3 and 4 of that table;

115

ANNEX II
Restrictions on materials and articles

1. Plastic materials and articles shall not release the following substances in quantities exceeding the specific migration limits below:

  • Aluminium = 1 mg/kg food or food simulant
  • Barium = 1 mg/kg food or food simulant
  • Cobalt = 0,05 mg/kg food or food simulant
  • Copper = 5 mg/kg food or food simulant
  • Iron = 48 mg/kg food or food simulant
  • Lithium = 0,6 mg/kg food or food simulant
  • Manganese = 0,6 mg/kg food or food simulant
  • Nickel = 0,02 mg/kg food or food simulant
  • Zinc = 5 mg/kg food or food simulant.

2. Primary aromatic amines which are not listed in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant in accordance with Article 11(4). The detection limit referred to in the second subparagraph of Article 11(4) applies to the sum of primary aromatic amines released.

116

ANNEX II
Restrictions on materials and articles

The following restrictions on plastic materials and articles apply:

1. Plastic materials and articles shall not release the substances in Table 1 below in quantities exceeding the specific migration limits expressed in mg/kg food or simulant specified in column (3), and subject to the remarks in Column (4).

Substances listed in Table 1 shall only be used in accordance with the compositional requirements set out in Chapter II. If Chapter II does not provide a basis for the authorised use of such a substance, that substance may only be present as an impurity subject to the restrictions specified in Table 1.

Table 1
General list of migration limits for substances migrating from plastic materials and articles

(1) (2) (3) (4)
Name Salts allowed in accordance with Article 6(3)(a) SML [mg/kg food or food simulant] Remark
Aluminium yes 1
Ammonium Yes (1)
Antimony No 0,04 (2)
Arsenic No ND
Barium Yes 1
Cadium No ND (LOD 0,002)
Calcium Yes (1)
Chromium No ND (3)
Cobalt Yes 0,05
Copper Yes 5
Europium Yes 0,05 (4)
Gadolinium Yes 0,05 (4)
Iron Yes 48
Lanthanum Yes 0,05 (4)
Lead No ND
Lithium Yes 0,6
Magnesium Yes (1)
Manganese Yes 0,06
Mercury No ND
Nickel No 0,02
Potassium Yes (1)
Sodium Yes (1)
Terbium Yes 0,05 (4)
Zinc Yes 5

ND: Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4); LOD: specified Limit of Detection.

Remarks

(1) The migration is subject to Article 11(3) and Article 12

(2) The note in Annex I, Table 1, FCM No 398 applies: SML might be exceeded at very high temperature

(3) To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply.

(4) The lanthanide substances europium, gadolinium, lanthanum, and/or terbium can be used in accordance with Article 6(3)(a) provided that:

(a) The sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg; and

(b) analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16.

2. Primary aromatic amines (‘PAAs’) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 1 ) and for which no migration limit is specified in Table 1 of 1

Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant. They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine (‘PAA’), in accordance with Article 11(4).

For PAAs not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006, but for which no specific migration limit is specified in Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19. The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant.

( 1 ) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).;

38

ANNEX I
Substances (authorised to be in the plastic and their limits)…

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
236 23050 0000108-45-2 1,3-phenylenediamine No Yes No ND
38

ANNEX I
Substances (authorised to be in the plastic and their limits)…

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
236 23050 0000108-45-2 1,3-phenylenediamine No Yes No ND (28)
50
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
398 35760 0001309-64-4 antimony trioxide Yes No No 0,04 SML expressed as antimony (6)
50
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
398 35760 0001309-64-4 antimony trioxide Yes No No (6)
105 New for M15 105
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
1075 Montmorillonite clay modified with hexadecyltrimethyl- ammonium bromide Yes No No Only to be used as additive at up

to 4,0 % w/w in polylactic acid

plastics intended for long-term

storage of water at ambient

temperature or below.

Can form platelets in the

nanoform that are in one or two

dimensions thinner than 100 nm.

Such platelets shall be oriented

parallel to the polymer surface

and shall be fully embedded in

the polymer.

1076 1227937-46-3 Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega- hydroxypoly[oxy(methyl-1,2- ethanediyl)], C10-16 alkyl ester 0,05 Only to be used as an additive at up to 0,2 % w/w in high impact polystyrene materials and articles intended contact with food at

room temperature and below,

including hot-fill and/or heating

up to 100 °C for up to 2 hours. It

shall not be used in contact with

foods for which simulant C and/or

D1 is assigned in Annex III.

1077 Titanium dioxide surface-treated with fluoride-modified alumina Only to be used at up to 25,0 % w/w, including in the nanoform. 29
112 New for M15 113 (28) A detection limit of 0,002 mg/kg food or food simulant applies

(29) In polar polymers which swell in contact with foods for which simulant B is assigned in Annex III, there is a risk that under severe contact conditions the migration limits for aluminium and fluoride are exceeded. Under contact conditions above 4 hours at 100 °C this exceedance can be high.

125 (6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions; 127 (6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.

At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,

— that are subject to restrictions in Annex II, or

— for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0,00015 mg/kg food or food simulant;

New for M15 130 (iv) if the plastic material or article intended to come into contact with food of which the compliance must be verified becomes in its final application part of a food processing equipment or an appliance, or a part thereof, the migration tests may be carried out by determining the specific migration into the food or food simulant produced or processed by the whole equipment or appliance, or the part thereof, as appropriate, subject to the following conditions:

— the food or food simulant is processed during testing by the equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or its part is operated in accordance with its operating instructions, and

— the migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use.

When migration testing is done under the above conditions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the migration limits, the plastic parts or materials present in the equipment or appliance shall be considered to complywith Article 11(1).

The testing of the parts used for storage or supply such as reservoirs, containers, capsules or pads shall be under conditions representative of their use, and shall include the foreseeable storage conditions of the food in these parts.

The supporting documentation referred to in Article 16 shall clearly document the testing on the whole food processing and/or food producing equipment or appliance, or on parts thereof. It shall demonstrate that the testing was representative of its foreseeable use, and shall indicate for which substances migration testing was carried out and provide all testing results. The manufacturer of individual plastic parts shall ensure the absence of migration for substances for which the Regulation specifies that their migration shall not be detectable at a specified level of detection in accordance with Article 11(4).

Compliance documentation supplied in accordance with the Regulation to the producer of the final equipment or appliance, or part thereof, shall list all substances subject to migration limits that might be exceeded under the foreseeable use of the supplied part or material.

When the result is not in compliance with the Regulation it shall be determined whether the source of the non-compliance is a plastic part subject to the Regulation or a part made from another material not subject to the Regulation on the basis of documentary evidence or analytical testing. Without prejudice to Article 3 of Regulation (EU) No 1935/2004, non-compliance to the Regulation shall only be established if the migration originates from a plastic part.

130 2.1.6. Repeated use articles

If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. Its compliance shall be checked on the basis of the level of the migration found in the third test.

However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.

133 2.1.6. Repeated use materials and articles

If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. The specific migration in the second test shall not exceed the level observed in the first test, and the specific migration in the third test shall not exceed the level observed in the second test.

Compliance of the material or article shall than be verified on the basis of the level of the migration found in the third test and on the basis of the stability of the material or article from the first to the third migration test. The stability of the material shall be considered insufficient if migration is observed above the level of detection in any of the three migration tests, and increases from the first migration test to the third migration test. In case of insufficient stability, compliance of the material shall not be established even in case the specific migration limit is not exceeded in any of the three tests.

However, if there is conclusive scientific proof that the level of the migration decreases in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.

Irrespective of the above rules, a material or article shall never be considered to comply with this Regulation if in the first test a substance that is prohibited from migrating or from being released in detectable quantities under Article 11(4) is detected.

Table 3
Standardised conditions for testing the overall migration

Column 1 Column 2 Column 3
Test number Contact time in days [d] or hours [h] at Contact temperature in [°C] for testing Intended food contact conditions
OM0
OM1 10 d at 20 °C Any food contact at frozen and refrigerated conditions.
OM2 10 d at 40 °C Any long term storage at room temperature or below, including when packaged under hot-fill conditions, and/ or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes.
OM3 2 h at 70 ° Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long term room temperature or refrigerated storage.
OM4 1 h at 100 °C High temperature applications for all types of food at temperature up to 100 °C.
OM5 2 h at 100 °C or at reflux or alternatively 1 h at 121 °C High temperature applications up to 121 °C.
OM6 4 h at 100 °C or at reflux Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1.
OM7 2 h at 175 °C High temperature applications with fatty foods exceeding the conditions of OM5.

Test OM7 also covers food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents the worst case conditions for food simulant D2 in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in Section 3.2.

Test OM6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B, C and D1 in contact with non-polyolefins.

135

Table 3
Standardised conditions for testing the overall migration

Column 1 Column 2 Column 3
Test number Contact time in days [d] or hours [h] at Contact temperature in [°C] for testing Intended food contact conditions
OM0 30 min at 40 °C Any food contact at cold or ambient temperatures and for a short duration (= 30 minutes).
OM1 10 d at 20 °C Any food contact at frozen and refrigerated conditions
OM2 10 d at 40 °C Any long-term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C = T = 100 °C for a maximum of t = 120/2^((T-70)/10) minutes.
OM3 2 h at 70 °C Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C = T = 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long-term room temperature or refrigerated storage.
OM4 1 h at 100 °C or at reflux High temperature applications for all types of food at temperature up to 100 °C.
OM5 2 h at 100 °C or at reflux or alternatively

1 h at 121 °C

High temperature applications up to 121 °C.
OM6 4 h at 100 °C or at

reflux

Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1.
OM7 2 h at 175 °C High temperature applications with fatty foods exceeding the conditions of OM5.

Test OM 7 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.

133 OM3, and OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.

Test OM2 covers also food contact conditions described for OM1 and OM3.

136 Test OM 6 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.

Test OM 5 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.

Test OM 2 covers also food contact conditions described for OM0, OM1 and OM3.

133 3.2. Substitute overall migration tests for tests with food simulant D2

If it is not technically feasible to perform one or more of the tests OM1 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.

In case it is technically not feasible to perform OM7 with food simulant D2 the test can be replaced by either test OM8 or test OM9 as appropriate given the intended or foreseeable use. Both tests involve testing at two test conditions for which a new test sample shall be used for each test. The test condition that results in the highest overall migration shall be used to establish compliance with this Regulation.

136 3.2. Substitute overall migration tests for tests with food simulant D2

If it is not technically feasible to perform one or more of the tests OM0 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest overall migration shall be used to establish compliance with the Regulation.

In case it is technically not feasible to perform OM7 with food simulant D2, either test OM8 or test OM9 shall be selected as a replacement test by selecting the most appropriate of these two tests on the basis of the intended and the foreseeable use of the material or article that is being tested. Subsequently, a migration test shall be done at each of the two test conditions specified for the selected test, using a new test sample for each test condition. The test condition that results in the higher overall migration shall be used to establish compliance with the Regulation.

133

134
3.3.2. Repeated use articles and materials

The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004. The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.

If it is not technically feasible to test the same sample three times, such as when testing in oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, it shall not be higher than the first result and the difference between the second and the first test results.

By derogation from the first paragraph, if, on the basis of scientific evidence, it is established that for the material or article being tested the overall migration does not increase in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient.

137 3.3.2. Repeated use articles and materials

The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625 of the European Parliament and of the Council ( 1 ). The overall 1 migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.

If it is not technically feasible to test the same sample three times, such as when testing in vegetable oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, the difference between the second and the first test results shall be lower than the first test results and the difference between the third and the second test results shall be lower than the difference between the second and the first test results.

By derogation from the first paragraph, if, on the basis of scientific

evidence, it is established that for the material or article being tested the overall migration decreases in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient.

Summary

The changes to the legislation are many and complex, but if you’re a site that purchases packaging here’s what you need to know.

There have been amendments to migration limits and the way that testing has to be completed, so you need to speak to your packaging suppliers to establish if the changes affect your packaging. And if they do, you need to request new migration certificates, once the supplier has completed any required testing.

If you’re a manufacturer of packaging, you need to understand the changes in much more detail as you’ll need to assess all of your packaging, to establish if a) it complies and b) if you need to redo your migration testing.

Any packaging that has been produced and placed on the market before 23rd March 2021 does not need to comply with the changes to the legislation.

However, all packaging, including that already on the market, must be compliant by 23rd September 2022.

Therefore, we have some time to make the required changes and run out any existing packaging that doesn’t comply.

If you have any questions regarding the changes please add them to the comments box below.

Have your say…

5 thoughts on “Amendment to EU No 10/2011 on plastic materials and articles intended to come into contact with food

  1. Hi, nice work !

    Just to mention some mistake in the copy of table 3 : where it is written (new version) “70 °C = T = 100 °C”, it should be read as “70 °C ≤ T ≤ 100 °C” like in the old one 😉

    1. Hi Patricia
      I appreciate that out of all the legislation that we have to deal with – this is probably the most complicated, as there is so much chemistry in it. Trying to simplify it, is really hard and also we need to be careful not to spend too much time getting into the detail (because there’s only a certain level of detail that we need to know). Those that really need to understand this legislation are those that request migration testing of their materials. At food sites we just need to know that they’ve done their job right.
      We are working on the detail, and it’s my intention to write about what you need to look for, when you’re assessing that your packaging suppliers – to make sure they’ve got it covered. Bear with while we do this – we have some time yet and we also need to give the packaging sites time to work through the changes as well.
      I hope that’s ok?
      Kassy

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